The document compares prescription and over-the-counter (OTC) medicines. Prescription medicines require a doctor's authorization, while OTC medicines do not. Prescription medicines undergo rigorous review by the FDA, while OTC medicines adhere to FDA monographs. The document also provides details on common types of OTC medicines like analgesics, including aspirin, ibuprofen, acetaminophen, and opioid combination drugs.

1. OVER-THE-
COUNTER
MEDICINES VS
PRESCRIPTION
MEDICINES

2. PRESCRIPTION DRUGS AND OVER-THE-COUNTER
(OTC) DRUGS
Prescription Drug Over-the-counter Drugs (OTC)
 Prescribed by a doctor  Drugs that do NOT require a doctor's prescription
 Bought at a pharmacy  Bought off-the-shelf in stores
 Prescribed for and intended to be used by one
person
 Regulated by FDA through the New Drug
Application (NDA) process. This is the formal step
a drug sponsor takes to ask that the FDA consider
approving a new drug for marketing in the United
States. An NDA includes all animal and human
data and analyses of the data, as well as
information about how the drug behaves in the
body and how it is manufactured. For more
information on the NDA process, please see "The
FDA's Drug Review Process: Ensuring Drugs Are
Safe and Effective."
 Regulated by FDA through OTC Drug
monographs. OTC drug monographs are a kind of
"recipe book" covering acceptable ingredients,
doses, formulations, and labeling. Monographs
will continually be updated adding additional
ingredients and labeling as needed. Products
conforming to a monograph may be marketed
without further FDA clearance, while those that
do not, must undergo separate review and
approval through the "New Drug Approval
System."

3. PRESCRIPTION DRUGS AND OVER-THE-COUNTER
(OTC) DRUGS
Prescription Drug Over-the-counter Drugs
(OTC)
Meaning Prescription drugs are
available only by
recommendation of an
authorized health
professional, such as a
physician.
Nonprescription (over-
the-counter, or OTC)
drugs are available on
request and do not
require approval by a
health professional.
Public views More potent and
frequently dangerous
Minimally effective and
safe

4. OVER-THE-COUNTER (OTC) DRUGS INTERESTING
FACTS
 Each year the U.S. spends over 14 billion on OTC drugs
 More than 300,000 different OTC products are available on the
market
 OTC expenditures comprise 60 of the annual drug purchase in the
U.S.
 An estimated 3 out of 4 people routinely self- medicate with these
drug products

5. TYPES OF OVER-THE-COUNTER (OTC)
DRUGS
 Internal analgesic
 An analgesic or painkiller is
any member of the group of
drugs used to achieve
analgesia, relief from pain.
They are distinct from
anesthetics, which temporarily
affect, and in some instances
eliminate, sensation.
(Wikipedia,2021)
Internal
analgesic
Analgesic
Salicylates

6. TYPES OF ANALGESICS
 analgesic combinations
 antimigraine agents
 CGRP inhibitors
 cox-2 inhibitors
 miscellaneous analgesics
 narcotic analgesic combinations
 narcotic analgesics
 Nonsteroidal anti-inflammatory drugs
 salicylates

7. TYPES OF ANALGESICS
Analgesic combinations
contain at least one analgesic in combination
with another medicine or medicines.
tend to either have acetaminophen, an
NSAID (such as ibuprofen or naproxen),
codeine (or another opioid) as one of their
ingredients.

8. CALCITONIN
GENE-RELATED
PEPTIDE (CGRP)
 Inhibitors block the
effect of CGRP, which is a
small protein that is
highly prevalent in the
sensory nerves that
supply the head and the
neck.

9. TYPES OF CALCITONIN GENE-RELATED
PEPTIDE (CGRP)
 Monoclonal antibodies
 Target either CGRP or the CGRP receptor and are used for
migraine prevention.
 Collection of identical proteins that have been developed
to only target one substance in the body.
 They are given by injection subcutaneously (under the
skin), to avoid degradation by the stomach. Because they
are large molecules, they take longer to start working and
work in the lining of the brain rather than in the brain
itself.

10. TYPES OF CALCITONIN GENE-RELATED
PEPTIDE (CGRP)
 Monoclonal antibodies and CGRP receptor
antagonists (gepants).
 Target either CGRP or the CGRP receptor and are used for
migraine prevention.
 Collection of identical proteins that have been developed to only
target one substance in the body.
 They are given by injection subcutaneously (under the skin), to
avoid degradation by the stomach. Because they are large
molecules, they take longer to start working and work in the lining
of the brain rather than in the brain itself.

11. TYPES OF
COX-2
INHIBITORS
 COX-1 and COX-2
 Both types produce prostaglandins;
 COX-1
 produce baseline levels of
prostaglandins that activate platelets
and protect the lining of the
gastrointestinal tract
 COX-2
 responsible for releasing
prostaglandins after infection or injury.

12. USES OF
COX-2
INHIBITORS
 COX-2 inhibitors may be used to treat
mild-to-moderate pain or inflammation
caused by a wide range of conditions such
as:
 Ankylosing spondylitis
 Hereditary polyps of the colon
 Juvenile rheumatoid arthritis in children
aged from two years
 Menstruation
 Osteoarthritis.
 COX-2 inhibitors may also be used to treat
acute pain such as that experienced with
sports injuries.

13. MISCELLANEOUS
ANALGESICS
Miscellaneous analgesics are those analgesics
that don’t fit into a particular class of analgesic
because they work in a different way to relieve
pain. That means they do not work like an opioid,
nor do they work like an NSAID.

14. MISCELLANEOUS ANALGESICS
 Acetaminophen is used to relieve pain caused by a wide variety of conditions, for
example:
 headaches
 migraines
 osteoarthritis
 rheumatoid arthritis
 sprains and strains
 a toothache.
 It may also be used to relieve pain caused by menstruation; however, it is not as effective as
NSAIDs.
 Ziconotide is reserved for people with severe chronic pain that has not responded
to other pain-relieving medications.

15. NARCOTIC
ANALGESIC
COMBINATIONS
 Products that contain a
narcotic analgesic in
combination with at least one
other analgesic; for example,
hydrocodone and
acetaminophen, oxycodone
and acetaminophen.

16. NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS
 Relieve pain and fever and reduce inflammation.
 There are nearly two dozen different NSAIDs
available, but they all work in the same way, and that
is by blocking a specific group of enzymes called
cyclo-oxygenase enzymes, often abbreviated to COX
enzymes.

17. WHAT ARE NONSTEROIDAL ANTI-
INFLAMMATORY AGENTS USED FOR?
 NSAIDs are used to treat mild-to-moderate pain that
arises from a wide range of conditions such as headaches,
menstruation, migraines, osteoarthritis or rheumatoid
arthritis, sprains and strains, and toothache.
 Aspirin is a NSAID that is used in small doses to lower the
risks of having a heart attack or a stroke caused by a
blood clot.

18. SALICYLATES
 A salicylate is a salt or ester of salicylic acid.
 Found naturally in some plants (such as white willow
bark and wintergreen leaves) and are thought to
protect the plant against insect damage and disease.

19. USES OF
SALICYLATES
 Salicylates are used as food
preservatives and antiseptics and
have bacteriostatic, fungicidal and
keratolytic (skin peeling)
properties.
 Salicylic acid and acetylsalicylic
acid have analgesic (pain relieving),
anti-inflammatory, and antipyretic
(temperature-lowering) effects.

20. USES OF
SALICYLATES
 Salicylates are used as food
preservatives and antiseptics and
have bacteriostatic, fungicidal and
keratolytic (skin peeling)
properties.
 Salicylic acid and acetylsalicylic
acid have analgesic (pain relieving),
anti-inflammatory, and antipyretic
(temperature-lowering) effects.